Wexler Surgical, Inc.
5 catalogue numbers from TL8486.1, listed by Wexler Surgical, Inc., United States, under Trocar. 9 manufacturers in China are registered for this product code.
9manufacturers in China registered for this device type
5catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (4), Guangdong (2), Shanghai (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Changzhou 3R Medical Device Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 16 |
| Sunny Medical Device (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
| Shanghai INT Medical Instruments Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Tianck Medical Co., Ltd. | Huizhou | Guangdong | Manufacturer | 10 |
| Changzhou Lookmed Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 8 |
| Tianjin Ethylene Oxide Sterilization Technology Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 4 |
| Shanghai Microport EP Medtech Co., Ltd. | Shanghai | Shanghai | Manufacturer | 3 |
Record
| Listed by | Wexler Surgical, Inc., United States |
|---|---|
| FDA product code | DRC |
| Device type | Trocar |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1390 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-03-13 |
| Record revised | 2021-08-26 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TL8486.1 | In distribution | |
| TL8491.1 | In distribution | |
| TL8481.1 | In distribution | |
| TL8471.1 | In distribution | |
| TL8476.1 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cook | Cook Incorporated | 107 |
| Trocar | Doppkon Gmbh & Co. KG | 53 |
| Merit Advance® | Merit Medical Systems, Inc. | 39 |
| HeartSpan® | Merit Medical | 29 |
| Busse Hospital Disposables | Robert Busse & Co., Inc. | 22 |
| Argyle | Cardinal Health | 20 |
| Apple-Hunt Secondary Cannula | Coopersurgical, Inc. | 20 |
| HeartSpan® | Merit Medical Systems, Inc. | 16 |
| AngioDynamics | AngioDynamics, Inc. | 16 |
| Majestik® | Merit Medical Systems, Inc. | 14 |
| Ambler Surgical | Ambler Surgical, LLC | 12 |
| Argyle | Cardinal Health 200, LLC | 8 |
Showing 12 of 57. All products under Trocar
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.